[Methodological and regulatory features of clinical trials for behavioral and psychological symptoms in the course of dementia].

During the last few years there has been a growing awareness of behavioral and psychological symptoms of dementia (BPSD). These symptoms are usually classified in syndromes, which include psychosis, depression, agitation and sleep disturbances. BPSD have a major impact on the clinical course, prognosis and the quality of life of patients and caregivers. Moreover, BPSD considerably increase the social costs of dementia, since they often result in institutionalization. The therapy of BPSD was initially based on an empirical syndromic approach. However, in more recent years the efficacy and safety of treatments for these conditions have been tested in several controlled clinical trials. This paper addresses some of the methodological and regulatory issues that are relevant to the conducting of clinical trials for BPSD.